510(k) · Cleared
Recalled · Class II · 2026Spectrum Central Venous Catheter with or Without Hydrophilic Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 12, 2004 as substantially equivalent to K950118 (Cook, Inc., 1996) after a 246-day review. Its family tree reaches back 1 generation to 1996. 1 of the 35 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it. It has been recalled 10 times.
- Decided
- Aug 12, 2004
- Review
- 246 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950118 (1996). 33 later devices descend from it, 2 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK950118 Abrm CatheterCook, Inc. · 1996 · Recalled
- This deviceK033843 Spectrum Central Venous Catheter with or Without Hydrophilic CoatingCook, Inc. · 2004
- Descendant · cites it directly · 32 of its ownK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
- Descendant · cites it directly · 31 of its ownK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 3 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
- Descendant · 3 generations on · 14 of its ownK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131260 Nmi Dialysis Catheter4 generations on · 2014
Most influential descendants
Showing 5 of 33 · See all- K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006 · cites it directly32descendants
- K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · cites it directly31descendants
- K101326NMI ICNavilyst Medical, Inc. · 2010 · 2 generations on26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 3 generations on23descendants
- K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950118 | Abrm Catheter | Cook, Inc. | 1996 | 1 |
| 0 (this device) | K033843 | Spectrum Central Venous Catheter with or Without Hydrophilic Coating | Cook, Inc. | 2004 | — |
| +1 | K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm | Cook, Inc. | 2006 | — |
| +1 | K081113 | Cook and Cook Spectrum Central Venous Catheters | Cook, Inc. | 2008 | 105 |
| +2 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +3 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
| +3 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 1 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950118 | Abrm CatheterSummary page 1…turer Device 5 10(k) Number Cook Incorporated ABRM Central Venous Catheter K9501 18 In terms of section 510(k) substantial equivalence, the device is identical in terms of design, intended use and technological ch… | 1996 |
What descends from it? (33)
See all 332 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-1788-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Mar 6, 2020 | Class II | Z-1566-2020 | Under Investigation by firm | The printed expiration dates are incorrect. |
| Jul 31, 2017 | Class II | Z-0634-2018 | Process control | Central venous catheters may not fit over guide wire potentially causing procedure delay. |
| Nov 28, 2016 | Class II | Z-0733-2017 | Mixed-up of materials/components | Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing… |
| Oct 4, 2010 | Not classified | Z-1157-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1107-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1106-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1158-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1109-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1108-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
The 5 latest of 10 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The Spectrum® Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as treatment for existing infections. The device is a short-term use catheter, supplied sterile and intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033843 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033843: Spectrum Central Venous Catheter with or Without Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033843
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026